那西妥单抗 (Danyelza)

概览

Naxitamab is a GD2-targeted IgG1 monoclonal antibody for the treatment of high-risk relapsed/refractory neuroblastoma of the bone or bone marrow.

作用机制

Neuroblastomas are neuroendocrine tumors occurring in immature and developing cells of the nervous system and are the most common malignancy diagnosed in children <1 year of age. The GD2 disialoganglioside is a glycolipid found highly expressed on the surface of neuroectodermal tumors, including neuroblastomas. GD2 exhibits high density and homogeneity across neuroblastomas and a rare occurrence of antigen loss, making it a desirable target in the treatment of these cancers. Naxitamab is an IgG1 monoclonal antibody directed against GD2 disialogangliosides - it binds to GD2 on the surface of neuroblastoma cells and induces both complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), the latter of which is enhanced by co-administration with GM-CSF.

适应症

Naxitamab-gqgk is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of patients 1 year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

• High risk, refractory Neuroblastomas of the bone or bone marrow
• High risk, relapsed Neuroblastomas of the bone or bone marrow